PureWeb BNJ Final_redact_Redacted.pdf

JUSTIFICATION AND APPROVAL

BRAND NAME

CONNECTED CARE INTEGRATED NETWORK

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Acquisition Operations Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, Suite 400 Fredericksburg, VA 22408

2. Description of Action:

The purpose of this action is to justify VA’s need for brand name items for the Connected Care Integrated Network (CCIN) Indefinite-Delivery, Indefinite-Quantity (IDIQ) Contract. The required items are commercial-off-the-shelf (COTS) software licenses used to deliver VA health care services to Veterans. The VA’s connected care technology network includes the combined VA ecosystem of clinical video equipment and software; store and forward technologies; web and mobile health applications;

software-as-a-service (SaaS) technologies; commercial-off-the-shelf (COTS) software products; mobile medical devices, peripherals, and wearables; remote patient monitoring technologies; online health portals; future connected care technologies; and ancillary items. The network supports the delivery of Mobile Applications, Telehealth services, including Clinical Video Telehealth (CVT) via the Clinical Enterprise Video Network (CEVN), Store and Forward Telehealth (SFT), Home Telehealth (HT), and the My HealtheVet online patient platform.

This Brand Name Justification (BNJ) for PureWeb brand name products only covers a portion of the procurement, currently identified as four (4) out of 126 contract line items in accordance with (IAW) Attachment 3 to the PWS titled CCIN Product List, which is primarily comprised of services. As described more fully below, the brand names are required for seamless operation of the connected care technology network as detailed below. Aside from these 4-line items and separate BNJs, the procurement will be solicited as Full and Open Competition and is being conducted utilizing FAR part 12 in conjunction with FAR part 15 and ordering will be in accordance with FAR 16.504.

3. Description of Supplies or Services:

The Office of Connected Care (OCC) established a connected care technology network for the distribution of health care, self-care, and related services that consists of telehealth devices, web and mobile medical applications, and online health platforms.

These connected care technologies expand the operations of VA’s expansive health care network by remotely connecting Veterans with health care professionals who can best meet their needs.

The scale of VA’s connected care program and its basis is unique. The products and services provided by OCC comprise the largest, most innovative virtual care program in the US, used throughout all 50 states and US territories.

VA-developed products require highly specialized industry support to successfully perform at the scope and complexity required by all connected care integrated network functions. These efforts must be delivered at a national level and the processes must be orchestrated from product inception through to enhancement and operational maintenance with products and services delivered by highly specialized staff.

CCIN Requirements

In service of VA’s mission to leverage connected care technologies to enhance care accessibility, capacity, quality, and satisfaction, OCC requirements are to provide connected care integrated network services, including the following linked functional areas (FAs):

FA 1: Product Ordering, Inventory, and Asset Management – Covers the ordering and distribution of connected care products from CCIN and the Connected Care Product Catalog (CCPC) as well as the inventory and asset management for connected care equipment and software licenses that support health care in all forms delivered from a distance (i.e., synchronous, asynchronous, and remote patient monitoring), including primary care, mental health, and specialty care such as dermatology, vision/eye, radiology, urgent care, intensive care, and many others.

FA 2: Help Desk Support – Provides 24x7x365 help desk support for all currently fielded and future connected care technologies.

FA 3: Connected Care Technology Software and Mobile Medical Application Design, Development, Enhancement, and Remediation – Includes all services required to design, develop, enhance, and remediate web and mobile medical applications, online platforms, and telehealth software. This development includes a mix of custom-developed code and modified commercial-off-the-shelf (COTS) products.

FA 4: Infrastructure and Architecture Support – Ensures support for the backend unified infrastructure and architecture for mobile applications and other connected care technologies, including the policies, shared services, and development and testing pipeline for app production release functions as necessary for the ongoing operation, maintenance, and release of new and existing web and mobile medical applications. (Note: Shared services refer to software code that is written for common functions and is reused across multiple applications and functions, i.e., patient lookup service.)

The four (4) FAs are performed cohesively to ensure minimum downtime for Veteran access to virtual care and requires a single contractor to lessen the risk of overlap, duplication, and delayed responses to operations.

Additionally, the Contractor shall be required to purchase certain products (i.e., mobile device data plans and maintenance, COTS software product licenses) that are necessary to provide support services in the functional areas listed above. These products are detailed in Attachment 3 to the PWS, CCIN Products List.

The period of performance is anticipated to be five-years from the date of award, with two, one-year performance-based optional ordering periods.

This BNJ covers the PureWeb brand name products detailed below throughout the period of performance. The estimated value of this BNJ is

The following summary includes the PureWeb brand name product description, the requirement, estimated value, a brief justification, and impact to the program.

Product Description: PureWeb’s ResolutionMD® software is FDA certified mobile medical imaging software that allows doctors and specialists to securely share and view patient images and reports from any computer or device, while collaborating remotely.

VA holds a perpetual product software license for Resolution MD® with unlimited seats.

Nationwide, VA has installed and runs Picture Archive and Communication systems (PACS) at individual medical centers and regions, manufactured by multiple vendors.

PACS systems store medical images and reports used in the diagnosis and treatment of diseases. Each PACS system is configured to route images to the VA’s Vista Image Exchange (VIX) server, which serves as VA’s only national storage repository for all VA patient images. In addition, about 10% of radiology images, are routed to the VA’s National Teleradiology Program’s (NTP) PACS system for temporary storage.

ResolutionMD® has been configured and integrated into VA information systems, branding the VA’s version of the product as Image Viewing Solution (IVS). Integration efforts have involved configuring the product to use VA authentication (user login) and patient search as well as retrieving images from VA’s Vista Image Exchange (VIX) servers and VA’s National Teleradiology (NTP) Picture Archiving systems (PACS). VA’s IVS software can be used by any authorized VA provider to view medical images stored on VA’s VIX server or the NTP PACS. The IVS software is used primarily for Telestroke providers who deliver care remotely across all VA facilities and have a need to view diagnostic quality medical images in real time, regardless of the individual PACS manufacturer used by the individual VA facility.

VA is buying: VA is procuring annual software maintenance for the currently fielded ResolutionMD® software. Software maintenance is the process of enhancing and optimizing software, as well as remedying defects; it includes technical support and all new fixes, patches, releases, updates, upgrades, security improvements, and feature enhancements that ensures the software solution stays in alignment with current medical protocols.

Estimated dollar value: over the life of the contract.

Justification: Due to the proprietary nature of the PureWeb ResolutionMD® software, only PureWeb and its authorized resellers are capable of providing maintenance support to meet all of the Government’s requirements because any other source would need access to the PureWeb proprietary source code in order to maintain VA’s IVS software. ResolutionMD® is PureWeb’s proprietary software which supports diagnostic quality imaging used in making medical determinations, thus it is classified as a medical device by the FDA. In accordance with the United States Food, Drug, and Cosmetic Act, 21 U.S.C. §510(k), only the certification holder (PureWeb) can make modifications to the medical device solution without voiding its FDA 510(k) certification. Furthermore, access to the proprietary source code is critical to meet VA’s need to maintain the current PureWeb ResolutionMD® software with bug fixes, security improvements, and feature enhancements that ensures the solution stays in alignment with current medical protocols.

Market research and technical experts have confirmed that no other source exists that can provide the required software maintenance and technical support without access to ResolutionMD® PureWeb’s proprietary code. Specifically, without access to this code, a vendor other than PureWeb or its authorized resellers would not be able to remedy defects by pushing patches, fixes, releases and updates through to the currently fielded software.

Impact by the failure to obtain a brand-name product: Failure to procure PureWeb Resolution proprietary software maintenance would be detrimental to the operability of the existing infrastructure and the functionality of VA’s IVS software. The failure of maintaining ResolutionMD® as current and operational would have a deleterious effect on VA’s ability to provide patient care to Veterans due to the inability of a provider to quickly assemble existing patient images from across all VA facilities in an emergency situation and for multiple providers to access and share diagnostic quality images when expert consultation services are required. Thus, only PureWeb or an authorized reseller can provide the software maintenance necessary to meet the Government’s requirement. As ResolutionMD is configured and integrated into VA information systems, implementing an entirely new software system would cause a substantial duplication of costs to the Government. New product integration with VistA Imaging would include; containerization of the code, preparation for the mobile publishing pipeline, remediation of security and software defects found in automated quality code scans. Use of a software other than PureWeb would cause a substantial duplication of cost and is estimated to take 1-2 years to accomplish at a total cost of approximately

A new COTS product would need to be modified in order to work within the VA environment, integrated with all necessary systems and applications, and comply with all security reviews and requirements; this is estimated to cost Concurrent with the software integration, the new product would also have to receive an Authority to Operate (ATO) which typically takes between 1-2 years and costs about

. Finally, licensing costs for a new product are estimated to be around annually.

4. Statutory Authority:

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, for brand name applications.”

5. Rationale Supporting Use of Authority Cited Above:

This is a brand name justification in accordance with FAR 11.105, Items Peculiar to One Manufacturer. The overall CCIN requirement consists primarily of critical services as well as products integrated into that support needed to maintain VA’s connected care technology network, including web and mobile applications and Telehealth Services enterprise CEVN/CVT, SFT, and HT.

The brand name products identified in PWS Attachment 3 are proprietary to the manufacturer listed above. As described and justified more fully above in Section 3, the brand name products are major components of VA’s connected care technology network and are essential to the Government’s requirements. Based on extensive market research, as described in section 8 of this document, it was determined that only the following brand can meet the Government’s requirements:

PureWeb: VA holds a perpetual license for this proprietary software. Only the manufacturer or its authorized reseller(s) are capable of providing the necessary maintenance and service because of its proprietary nature.

Use of other than the identified brand products would cause a significant interruption to direct patient care, create unnecessary risks to patient safety, and introduce potential security vulnerabilities, at a level unacceptable to VA’s mission, and the connected care technology network. Additionally, the Government would experience a significant increase in costs associated with delays in the delivery of connected care technology products and services and a disruption of VA’s ability to deliver digital patient care.

VA’s connected care capabilities have become a vital part of VA’s health care system.

The importance has never been more apparent than during the COVID-19 pandemic when record numbers of Veterans and VA health care professionals used virtual care for the first time to access VA care safely and virtually. From February to May 2020, week-over-week telehealth video appointments through VA Video Connect (VVC) increased by 1100%, from approximately 10,000 appointments a week in early February to more than 120,000 appointments a week in May. This rapid increase in video appointments was necessary to maintain safe clinical services during COVID-19 and was made possible by the expansion and reengineering of VA’s information technology infrastructure, rapid adoption by VA healthcare professionals, and an increase in VVC capacity to accommodate a greater number of concurrent users. In addition, in FY21, VA provided over 9.5 million documented video encounters to the home, for an average of 184,000 per week. This is still relevant today, as during the month of September 2022, telehealth video appointments averaged more than 35,000 daily visits an increase of more than 1600% from February 2020.

During a time of year-over-year growth of telehealth care provided by VA, including the significant growth during the COVID-19 pandemic, any delays and/or disruptions to the digital health technology network would have an even more dramatic negative impact on Veterans’ access to health care. This impact is even greater in rural areas where VA health clinics are not easily available, requiring Veterans to physically travel long distances to VA locations or receive care in the community, resulting in increased costs to the Government for reimbursements both in Veterans’ travel fees and private care providers and their facilities.

Use of any other brand name would cripple the operation of the current connected care technology network. Integration of new technologies other than those required by this justification into a new digital health technology network would cause a redevelopment of significant portions of VA’s connected care infrastructure, resulting in a monumental duplication of costs and a level of effort that would be almost impossible to recover through price reductions achieved through competition. The aftermath of this would result in an unprecedented cessation of virtual care services as well as mandated requirements for OCC to provide telehealth services as a result of the CARES Act, MISSION Act, Hannon Act and others. Additionally, PureWeb brand name items are being acquired to support an FDA-certified medical device system. As part of the certification, FDA stipulates that only the vendor or one of its authorized resellers can provide maintenance and support.

6. Efforts to Obtain Competition:

Market research was conducted as set forth in paragraph eight of this document. Three separate Requests for Information (RFI) have been posted to the public, as well as extensive research of federally approved, FDA-approved and VA-approved equipment and associated services. As required by FAR 5.201, this action will be synopsized through SAM (http://sam.gov/). In addition, this justification will be published in accordance with FAR 6.305(c). The solicitation shall be provided to the public via Contract Opportunities to reasonably ensure proposals are received from vendors who can fulfill the requirement.

7. Determination of Fair and Reasonable Price:

The Government anticipates the cost for this requirement will be fair and reasonable.

The Government may utilize historical pricing, commercially available pricelists, and comparison of proposed pricing received in response to the solicitation. The Government, in accordance with FAR 15.404-1(b)(2), may also use various price analysis techniques and procedures and reserves the right to do so to ensure a fair and reasonable price is obtained.

8. Market Research:

Market research was conducted through three Requests for Information (RFI) (July 2021, October 2021 and December 2021) utilizing the NAICS code is 334111 Electronic

Computer Manufacturing. These are commercial products. The most applicable Product Service Code (PSC) is 6515 – Medical and Surgical Instruments, Equipment, and Supplies, specifically as it relates to products that support patient care. The RFI dataset included responses from 4 companies. All respondents indicated they can provide 100% of the parts list, to include all brand name services identified in this document, with existing distributor agreements or ones that can be obtained, indicating that the Government will get significant competition for items identified in this brand name justification.

Additionally, a special notice was issued in November 2022 under NAICS code 541512 Computer - Systems Design Services and applicable Product Service Code (PSC) DA01 – IT and Telecom – Business Application/Application Development Support Services. The special notice provided industry with the CCIN performance work statement (PWS) and Attachment 3, CCIN Product List. The product list is inclusive of all products which will be purchased under this requirement. No questions were received from industry regarding the PureWeb brand name products.

Calgary Scientific provided a memo on November 30, 2022 stating that PureWeb Inc, as the parent company of Calgary Scientific Inc, is the sole manufacturer and developer of the ResolutionMD product and maintains all regulatory approval with, and requirements of the FDA. Additionally, this memo specifies that only PureWeb Inc. is authorized to provide support and maintenance of the ResolutionMD product.

Furthermore, market research confirms the above statement. An internet search performed on December 22, 2022 revealed that ResolutionMD streamlines workflows with HIPPA compliant collaboration features and mobile capabilities and maintains FDA Class II and other global accreditations. As outlined in section three (3) of this document, only the certification holder (PureWeb) can make modifications to the medical device solution without voiding its FDA 510(k) certification. A query of the FDA Medical Devices Database shows that Calgary Scientific’s 510(k) certification for ResolutionMD was approved on August 24, 2016. Lastly, market research shows that ResolutionMD is powered by the PureWeb software development platform.

9. Other Facts:

Not applicable.

10. Actions to Increase Competition:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable a deviation from the brand name requirement for future actions to be competed. Prior to exercising any option under this requirement, the VA will determine that exercise of options it the most advantageous method of fulfilling the Government’s need IAW FAR 17.207. VA will continue to monitor market trends, new/emerging products, looking for compatible and more advanced technologies to meet its needs.